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Savara Inc. (SVRA) reported its financial results for Q3 2022, highlighting a net loss of $10.4 million, consistent with the previous year. Research and development expenses rose by 24.8% to $8.2 million, driven by costs associated with the ongoing Phase 3 IMPALA-2 trial for molgramostim, an inhaled biologic for aPAP. The company ended the quarter with approximately $134 million in cash, expected to sustain operations through 2025. Additionally, Savara announced the appointment of Raymond Pratt, M.D. as Chief Medical Officer.
Positive
Top-line data from the Phase 3 IMPALA-2 trial is expected by the end of Q2 2024.
Company believes it has sufficient capital to operate through 2025, providing a stable financial outlook.
Appointment of Raymond Pratt, M.D. as Chief Medical Officer may enhance clinical development and regulatory leadership.
Negative
Net loss remained consistent at $10.4 million, indicating ongoing financial challenges.
Research and development expenses increased significantly, reflecting higher costs related to the IMPALA-2 trial.
Pivotal Phase 3 IMPALA-2 Trial Remains On-Track, Top Line Data Expected End of 2Q 2024
IMPALA-2 is evaluating molgramostim nebulizer solution (molgramostim), a novel inhaled biologic, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease
Received Acceptance from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) on a Revised Pediatric Investigation Plan (PIP) for Molgramostim in aPAP
Appoints Raymond Pratt, M.D., Chief Medical Officer
Company Ends Quarter with ~$134M, Believes it is Sufficiently Capitalized Through 2025
AUSTIN, Texas--(BUSINESS WIRE)--
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2022 and provided a business update.
“As we’ve said over the last year, challenges related to COVID and flu surges, geopolitical issues, and supply chain constraints are ongoing and will likely continue,” said Matt Pauls, Chair and CEO, Savara. “However, IMPALA-2, the pivotal Phase 3 trial of our novel inhaled biologic, remains on-track for a top line read-out by the end of 2Q 2024. Importantly, the Company has a strong balance sheet, and we believe we have more than three years of operating runway which is approximately 18 months beyond top line results. Finally, we are happy to announce the appointment of Raymond Pratt, M.D. as Chief Medical Officer, effective immediately. With approximately 30 years of global drug development experience, and numerous regulatory approvals, Dr. Pratt is a proven biopharmaceutical Chief Medical Officer, and we are confident that he will provide significant clinical development, medical affairs, and regulatory leadership.”
“I am delighted to join Savara as we advance the molgramostim development program,” said Raymond Pratt, M.D., newly appointed Chief Medical Officer, Savara. “I am impressed by the quality of the team and progress they have made executing the IMPALA-2 trial. I look forward to building on that momentum so that we can potentially fill the serious unmet needs of patients with aPAP.”
Third Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the three months ended September 30, 2022, was $10.4 million, or $(0.07) per share, compared with a net loss attributable to common stockholders of $10.5 million, or $(0.07) per share, for the three months ended September 30, 2021.
Research and development expenses increased by $1.6 million, or 24.8%, to $8.2 million for the three months ended September 30, 2022 from $6.5 million for the three months ended September 30, 2021. This was primarily due to approximately $0.7 million of costs related to our IMPALA-2 trial, including activities related to our Contract Research Organization and approximately $0.7 million of costs related to our Chemistry, Manufacturing, and Controls (CMC) activities.
General and administrative expenses decreased by $1.0 million, or 30.1%, to $2.4 million for the three months ended September 30, 2022 from $3.4 million for the three months ended September 30, 2021. This was primarily attributable to a reduction of approximately $0.7 million in consulting activities during the three months ended September 30, 2022.
As of September 30, 2022, Savara had cash, cash equivalents, and short-term investments of approximately $134 million and debt of approximately $26 million.
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH). Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the timing of the IMPALA-2 top line data read-out and that it is currently on-track to occur by the end of the second quarter of 2024, our belief the Company is sufficiently capitalized through 2025, that Dr. Pratt will provide significant clinical development, medical affairs, and regulatory leadership to Savara, and that Dr. Pratt looks forward to building on Savara’s momentum so we can potentially fill the serious unmet need in the treatment of aPAP. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks and uncertainties relating to the impact of the COVID-19 pandemic, the flu, or other widespread health concerns impacting healthcare providers or patients, disruptions or inefficiencies in the supply chain and geopolitical conditions on our business and operations, the outcome of our ongoing and planned clinical trials for our product candidate, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidate in a timely manner, the ability to successfully develop our product candidate, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as molgramostim that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
Financial Information to Follow
Savara Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except for share and per share amounts)
(Unaudited)
Three months ended
Nine months ended
September 30,
September 30,
2022
2021
2022
2021
Operating expenses:
Research and development
$
8,151
$
6,532
$
20,253
$
21,373
General and administrative
2,376
3,400
7,687
9,331
Depreciation and amortization
8
40
24
134
Total operating expenses
10,535
9,972
27,964
30,838
Loss from operations
(10,535
)
(9,972
)
(27,964
)
(30,838
)
Other income (expense), net:
149
(574
)
114
(866
)
Net loss attributable to common stockholders
$
(10,386
)
$
(10,546
)
$
(27,850
)
$
(31,704
)
Net loss per share - basic and diluted
$
(0.07
)
$
(0.07
)
$
(0.18
)
$
(0.25
)
Weighted average shares - basic and diluted
152,773,015
152,587,848
152,771,302
127,623,824
Other comprehensive (loss) gain
(591
)
(307
)
(1,612
)
(657
)
Total comprehensive loss
$
(10,977
)
$
(10,853
)
$
(29,462
)
$
(32,361
)
Savara Inc. and Subsidiaries
Condensed Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
September 30,
December 31,
2022
2021
Cash, cash equivalents, and short-term investments
